Quality Engineer

Insight Global; Raynham (MA); On-site; USD 94,000 - 112,000; Full time

Benefits offered by this job

Health insurance

401(k) after 90 days

Paid time off

Job summary

Insight Global is seeking a Quality Engineer to support a medical device client in Raynham, MA. This onsite role collaborates with Engineering, Manufacturing, R&D, and Quality to drive compliance, validation, risk management, and continuous improvement in a regulated environment.

The successful candidate will have 3–5+ years in quality engineering, knowledge of FDA QSR, ISO 13485/9001, and experience with product/process validations and risk assessments.

Qualifications

• Bachelor's degree in a related engineering field.
• 3-5+ years of quality engineering experience in a regulated industry.
• Experience with FDA QSR, ISO 13485 and ISO 9001.

Responsibilities

• Represent Quality on cross-functional teams for product launches.
• Develop, execute, and document validation protocols for products, processes, test methods, and software systems.
• Support revalidation after engineering changes, deviations, system upgrades, or material changes.
• Perform statistical analysis to support validation and establish process controls.
• Conduct quality risk assessments and apply risk management methodologies.
• Collaborate with R&D and Engineering to define CTQ characteristics.
• Lead Design for Inspection initiatives and reduce human error.
• Ensure compliance with FDA QSR, ISO 13485/ISO 9001 and internal quality system requirements.
• Support CAPA activities, investigations, and root cause analyses.
• Partner with manufacturing to resolve quality issues and improve production efficiency.
• Provide quality oversight to meet timelines and quality objectives.

Skills

Quality engineering

Risk assessment

Root cause analysis

Statistical analysis

Cross-functional collaboration

Project management

Design for Inspection

Documentation & compliance

Education

Bachelor's degree in Mechanical/Industrial/Quality Engineering

Job description

Job Description

Insight Global is hiring a Quality Engineer to support a medical device client out of Raynham, MA. This role is 5 days per week onsite. The Quality Engineer will serve as a key member of a cross‑functional team responsible for supporting new technology introductions, product transfers, and manufacturing quality initiatives. This individual will partner closely with Engineering, Manufacturing, R&D, and Quality teams to drive compliance, validation, risk management, and continuous improvement activities within a regulated medical device environment. The ideal candidate is a strong quality professional with experience supporting product and process validations, implementing quality systems, and ensuring compliance with FDA and ISO standards.

Day-to-Day Responsibilities

• Represent Quality on cross-functional teams to support new technology introductions and product launches into manufacturing.
• Develop, execute, and document validation protocols for products, processes, test methods, and software systems.
• Support revalidation activities resulting from engineering changes, deviations, system upgrades, or material changes.
• Perform statistical analysis to support validation activities and establish production inspection strategies and process controls.
• Conduct quality risk assessments and apply risk management methodologies during product and process development activities.
• Collaborate with R&D and Engineering teams to define and document Critical-to-Quality (CTQ) characteristics.
• Lead Design for Inspection initiatives and identify opportunities to improve inspection capabilities and reduce human error.
• Ensure compliance with FDA Quality System Regulations (QSR), ISO 13485, ISO 9001, and internal quality system requirements.
• Support investigations, root cause analyses, complaint handling, and corrective and preventive action (CAPA) activities.
• Partner with manufacturing teams to resolve quality issues, reduce compliance risks, and improve production efficiency.
• Provide quality oversight and guidance throughout project execution to support successful delivery against timelines and quality objectives.

Compensation:

$45/hr to $54/hr.

Exact compensation may vary based on several factors, including skills, experience, and education.

Employees in this role will enjoy a comprehensive benefits package starting on day one of

employment, including options for medical, dental, and vision insurance.

Eligibility to enroll in

the 401(k) retirement plan begins after 90 days of employment. Additionally, employees in this

role will have access to paid sick leave and other paid time off benefits as required under the

applicable law of the worksite location.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [e-mail] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Skills and Requirements

• Bachelor's degree in Mechanical Engineering, Industrial Engineering, Quality Engineering, or a related technical discipline.
• 3-5+ years of experience in a Quality Engineering role within a regulated industry.
• Experience supporting medical device manufacturing, product development, or new product introduction activities.
• Strong knowledge of product verification, process validation, and test method validation.
• Working knowledge of FDA Quality System Regulations (QSR) and medical device GMP requirements.
• Experience performing risk assessments, root cause investigations, and implementing corrective actions.
• Strong communication and cross-functional collaboration skills.
• Proven ability to manage multiple priorities and support projects in a fast-paced manufacturing environment.
• Medical device industry experience.
• Experience supporting new technology implementation and product transfers into production.
• Familiarity with ISO 13485 and ISO 9001 quality standards.
• Experience using statistical analysis tools to support validation and process improvement activities.
• Project management experience.
• Experience participating in Design for Inspection or manufacturing process improvement initiatives.